|
序号 No |
测试对象 Test Project |
国内/国际/行业标准 Testing Capability |
|
1 |
医用电气设备：通用要求 Medical electrical equipment |
YY 0505、EN/IEC 60601-1-2 GB 9706.1、EN/IEC 60601-1
|
|
2 |
医用电气系统 Medical Electrical Systems |
YY 0505、EN/IEC 60601-1-2 GB 9706.15、IEC 60601-1-1 |
|
3 |
家用医疗保健环境使用的医疗电气设备和医疗电气系统 Medical Electrical Equipment and Medical Electrical Systems used in the Home Health care Environment |
YY 0505、EN/IEC 60601-1-2 EN/IEC 60601-1-11 |
|
4 |
超声理疗设备 Ultrasonic physiotherapy equipment |
YY 0505、EN/IEC 60601-1-2 GB 9706.7、EN/IEC 60601-2-5 |
|
5 |
内窥镜设备 Endoscopic equipment |
YY 0505、EN/IEC 60601-1-2 GB 9706.19、EN/IEC 60601-2-18
|
|
6 |
手术、化妆、诊断和治疗激光设备 Surgical, cosmetic, therapeutic and diagnostic laser equipment |
YY 0505、EN/IEC 60601-1-2 GB 9706.20、EN/IEC 60601-2-22
|
|
7 |
自动循环无创血压监护设备 Automatic cycling non-invasive blood pressure monitoring equipment |
YY 0505、EN/IEC 60601-1-2 EN 60601-2-30 YY0667
|
|
8 |
自动非侵入式血压测量仪 Automatic cycling non-invasive blood pressure monitoring equipment |
YY 0505、EN/IEC 60601-1-2 EN/IEC 80601-2-30 |
|
9 |
有创血压监测设备 Invasive blood pressure monitoring equipments |
YY 0505、EN/IEC 60601-1-2 EN/IEC 60601-2-34 YY0783
|
|
10 |
热垫式治疗仪 Medical heating pad therapy equipment |
YY 0505、EN/IEC 60601-1-2 YY/T0165
|
|
…… |
…… |
…… |
|
序号 No |
测试对象 Test Project |
国内/国际/行业标准 Testing Capability |
|
1 |
测量、控制和实验室用电气设备的安全要求：通用要求 Safety requirements for electrical equipment for measurement control and laboratory use |
GB 4793.1、EN/IEC 61010-1 GB/T 18268.1、GB/T18268.26、 EN/IEC 60601-1-2
|
|
2 |
实验室用材料加热设备 Particular requirements for laboratory equipment for the heating of Materials |
GB 4793.6、EN/IEC EN61010-2-010 GB/T 18268.1、GB/T18268.26、 EN/IEC 60601-1-2
|
|
3 |
实验室用离心机 Particular requirements for laboratory equipment for laboratory centrifuges |
GB 4793.7、EN/IEC 61010-2-020 GB/T 18268.1、GB/T18268.26、 EN/IEC 60601-1-2
|
|
4 |
处理医疗材料用灭菌器和清洗消毒器设备 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
GB/T 18268.1、GB/T18268.26、 EN/IEC 60601-1-2 EN/IEC 61010-2-040
|
|
5 |
实验室用混合和搅拌设备 Laboratory mixing and stirring equipment |
GB 4793.3、EN/IEC 61010-2-051 GB/T 18268.1、GB/T18268.26、 EN/IEC 60601-1-2
|
|
6 |
实验室用分析和其他目的的自动或半自动设备的特殊要求 Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes |
GB4793.9、EN/IEC 61010-2-081 GB/T 18268.1、GB/T18268.26、 EN/IEC 60601-1-2
|
|
7 |
体外诊断医疗设备（IVD） |
GB 4793.1、EN/IEC 61010-2-101 YY 0648 GB/T 18268.1、GB/T18268.26、 EN/IEC 60601-1-2
|
|
…… |
…… |
…… |
|
序号 No |
测试对象 Test Project
|
国内/国际/行业标准 Testing Capability |
|
1
|
医用电气设备 Medical Electrical Equipment |
GB/T14710、GB/T 4857.23、ASTM D4169 |
|
…… |
…… |
…… |
